Research Project
9120856
? DESCRIPTION (provided by applicant): In Phase I, Biocrede developed a completely new urinary tract silicone Foley catheter with a >4.5 month shelf-life, made from a proprietary polymeric formulation to effectively reduce catheter-associated urinary tract infections (CAUTI) via nitric oxide (NO) release for >2 weeks. Key features of the new technology include: (1) catheters continuously deliver NO at bactericidal rates for >14 d at 37°C; (2) In vitro data demonstrate a 10,000 fold reduction of live bacteria counts (for key bacteria strains associated with CAUTI) on catheter surfaces and ability to prevent biofilm formation at 14 days; (3) ongoing study shows that shelf- life can easily be extended beyond >>4.5 months after ETO sterilization; (4) ISO/GLP leaching tests (1-3 d) and associated toxicity studies on cells (3 d) and in mice (3 d) received the safest scores possible; and (5) urologists praised the consistency, elasticity, and flexibility of the product compared to others. The NO released from the surfaces of the catheter quickly diffuses out of the silicone walls into the urine collection lumen and from the catheter's outer surface to prevent/disrupt biofilm formation that will eliminate CAUTIs. CAUTIs contribute to 0.5-0.7 million nosocomial hospital infections annually with a cumulative incidence of 3-6% per day of catheterization (50% at 10 days, >90% at 28 days, 100% long term) leading to complications such as cystitis, pyelonephritis, gram-negative bacteremia, prostatitis, epididymitis, urosepsis, septicemia, etc., in patients. This technology will help reduce the costs associated with CAUTIs ($700 per infection) and potentially prevent most of the 10,000 deaths/year due to CAUTIs in the US alone. To continue research and development of this advanced product, we propose to: (1) prove that NO releasing catheters can be stored for 12 months or more after EtO sterilization; (2) develop/assemble a controlled Allan Bradley automated system to allow repeatable SNAP (S-nitroso-N-acetyl-penicillamine) impregnation and lean operation efforts; (3) prove the safety, CAUTI prevention efficacy, and biocompatibility of our new NO releasing Foley catheter design via animal studies (rabbits) after 7 d and 14 d (n=8 each); (4) verify and design for lowest possible SNAP leaching; (5) perform all of the required GLP third party biocompatibility studies for future 510k application in 2015; (6) and receive the FDA IDE approval by 2016. Achieving these goals will allow Biocrede to work with investors to fund a future clinical Phase I pilot study, and clinical Phase II final study for our 510k (De novo) applications. Fortune Medical, an FDA approved and ISO13485 certified company, is Biocrede's catheter OEM provider; and Biocrede (100% US owned, Ann Arbor, MI) will add the proprietary components (SNAP impregnation technology), and perform quality control, sterilization and packaging. This proprietary technology is being licensed by Biocrede Inc. through the Offices of Tech Transfer at the University of Michigan (Ann Arbor, MI).
